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With MS & Fibrosis Trials Planned, J&J-Partnered Contineum Now Preps for IPO

Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression. By FRANK VINLUAN Jhnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the ...
- Source: drugdu
- 106
- March 20, 2024
FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma

Don Tracy, Associate Editor In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment. Johnson & Johnson (J&J) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) in earlier lines of treatment for adult patients with relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including both a proteasome inhibitor and an immunomodulatory agent, and who are also refractory to lenalidomide. The 11-0 unanimous vote in favor of the treatment resulted from Phase III CARTITUDE-4 study data, which showed an encouraging risk-benefit evaluation for its proposed indication.1 “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, VP, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, in a press ...
- Source: drugdu
- 158
- March 20, 2024
AZ/Merck’s Lynparza approved by SMC to treat advanced prostate cancer in Scotland

Up to 20% of prostate cancer cases are classified as castration-resistant AstraZeneca (AZ) and Merck & Co – known as MSD outside the US and Canada – have announced that the Scottish Medicines Consortium (SMC) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC). Affecting around one in ten men in Scotland, approximately 10% to 20% of prostate cancer cases are classified as castration resistant, evolving to resist androgen deprivation therapy, the standard of care. mCRPC occurs when the cancer has spread to other parts of the body, which is challenging to treat and results in a poor prognosis. The SMC’s decision was based on results from the phase 3 randomised, double-blind PROpel trial, which evaluated the efficacy, safety and tolerability of Lynparza versus placebo when given in addition to abiraterone in men with mCRPC who had ...
- Source: drugdu
- 137
- March 20, 2024
Birmingham’s VR-assisted training centre for excellence to support future vaccine makers

The centre will deliver free training, outreach materials and programmes The University of Birmingham is set to lead UK-wide virtual reality (VR)-assisted training in medicines manufacturing to address critical skills demand in life sciences. Set to benefit future medicine and vaccine makers, the new RESILIENCE Centre for Excellence for UK Medicines Manufacturing Skills Centre aims to deliver free training, outreach materials and programmes. Supported by £4.5m of funding from Innovate UK and the Office for Life Sciences, the centre will be led by an academic consortium of UK universities, including University College London, Teesside University and Heriot-Watt University. The training centre aims to work with healthcare and pharmaceutical organisations to provide a single-entry point for training and career input, which includes a pipeline of continuing professional development courses. Hundreds of students across the UK are set to benefit from the training developed by the RESILIENCE Centre, including VR and mixed ...
- Source: drugdu
- 109
- March 20, 2024
CanSinoBio (Shanghai) and AsymBio have entered into a strategic cooperation.

Recently, CanSinoBio (Shanghai) Biotechnology Co., Ltd (hereinafter referred to as “CanSinoBio Shanghai”) and AsymBio (hereinafter referred to as “AsymBio”) reached a strategic cooperation. (hereinafter referred to as “Kalein Biotech”). The two parties will aim at the cutting-edge technology innovation and industry market demand, and realize innovative collaboration and complementary advantages in the field of plasmid, mRNA, LNP biopharmaceutical macromolecules, and jointly promote the research and development and industrialization of mRNA technology. As a leading company in the vaccine field, CanSinoBio Shanghai has established an advanced mRNA technology platform in the industry, with independently designed and developed sequence optimization software, which can obtain the key sites affecting the stability and the optimal sequence to effectively improve the expression of antigens, and the CMC process is simple and concise, which can shorten the time of product development and quickly realize the industrialization of scientific research results. In addition, CanSinoBio has an advanced ...
- Source: drugdu
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- March 20, 2024
Merck Sharp & Dohme Announces Plans to Conduct Clinical Trials of New Multivalent HPV Vaccine and Gardasil®9 Single-Dose Vaccination Regimen

Rowe, N.J., March 13, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, N.J., U.S.A.) announced at the European Organization for the Study of Genital Infections and Neoplasms (EUROGIN) Congress 2024 plans to initiate a novel multivalent human papillomavirus (HPV) vaccine clinical trial designed to provide broader protection against HPV types. At the same time, Merck Sharp & Dohme also plans to conduct additional clinical trials to evaluate the protective efficacy and safety of Gardasil®9 [nine-valent human papillomavirus vaccine (brewer’s yeast)] single-dose regimen1 compared to the already approved three-dose regimen. Within China, Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the uterine cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and ...
- Source: drugdu
- 138
- March 20, 2024
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystroph

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” said Peter Marks, M.D., Ph.D., director of ...
- Source: drugdu
- 161
- March 20, 2024
BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
- Source: drugdu
- 155
- March 20, 2024
A Startup’s Flexibility With ADC Cancer Drugs Attracts €128M for Clinical Trials

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting. By FRANK VINLUAN The concept of an antibody drug conjugate, or ADC, is straightforward: a cancer-killing drug is chemically linked to an antibody that targets the delivery of the therapy to a tumor. This drug class has made progress with several approved products and many more on their heels in clinical development. But there’s still plenty of room to improve on this type of targeted cancer therapy, contends Dominik Schumacher, CEO of Tubulis. When an ADC releases its drug payload too early, it hits healthy tissue and sparks toxic effects, Schumacher said. Also, current ADC designs are restricted in their ability to match the biology of cancer ...
- Source: drugdu
- 161
- March 19, 2024
FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

Don Tracy, Associate Editor Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA has approved BeiGene’s Tevimbra (tislelizumab-jsgr) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA based the approval on findings from the Phase III RATIONALE 302 trial (NCT03430843), which showed a significant survival benefit with Tevimbra compared to chemotherapy, with an overall survival rate of 8.6 months compared with 6.3 months in patients administered chemotherapy. Further, the treatment was found to be safer altogether, with manageable adverse effects.1 “Today’s FDA approval of Tevimbra for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our [biologics license application] for first line ESCC patients, represents a significant step in our commitment ...
- Source: drugdu
- 146
- March 19, 2024

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